Post-COVID-19 Condition: Observational Study in Vietnam

NCT06022211 | Unknown

• 1 other identifier: ANRS 0268s POSTCOVIET
• Study Type: observational
• Target: 835
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to estimate the prevalence of the post-COVID-19 condition in confirmed mild, moderate, and severe COVID-19 adult patients in Hai Phong, Vietnam.

Conditions

Post COVID-19 Condition

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the proportion of participants who present a post-COVID-19 condition in adult patients with confirmed mild, moderate, and severe COVID-19 in Hai Phong, Vietnam.

  According to the WHO definition

  Day 0

Secondary Outcomes (3)

• Type and frequency of symptoms of the post-COVID-19 condition.

  Day 0

• Functional limitations among participants with the post-COVID-19 condition.

  Day 0

• Factors related to occurrence of post-COVID-19 condition in adults after mild, moderate, and severe acute COVID-19.

  Day 0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients hospitalised in Viet Tiep 2 hospital or Kien An hospital for moderate or severe acute COVID-19 3 to 12 months before inclusion, or registered in the provincial CDC database for mild COVID-19 that occurred 3-12 months before inclusion.

You may qualify if:

• Adults aged 18 years or more;
• Hospitalised in Viet Tiep 2 hospital or Kien An hospital (tertiary care hospitals) with moderate or severe COVID-19 or registered in provincial CDC health system for mild COVID-19;
• Accepting to participate in the study;

You may not qualify if:

• Not able to understand or answer a quick phone questionnaire;
• Individuals who refuse or cannot come to Viet Tiep 2 hospital in case of the suspected post-COVID-19 condition.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Biospecimen

Retention: SAMPLES WITH DNA

* 1 EDTA tube of 2 mL for complete blood count; * 1 heparinate tube of 2 mL for the biochemistry tests including glycaemia, transaminases, serum creatinine, CRP, ionogram (Na, K); * 1 EDTA tube of 2 mL for biobank (DBS and plasma). * 1 dry tube of 2 mL for HIV serology, HCV Ab, HBs Ag;

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 1, 2023
• Study Start: December 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 1, 2023

Record last verified: 2023-08